THE THRIVE ACT

Click here to read the version 2.0 of The THRIVE ACT.

BACKGROUND

The current US FDA regulatory process is designed for medical products that target specific diseases already present in patients. This framework does not suit products that extend healthspan, which often prevent diseases and/or target multiple age-related diseases at once. To demonstrate that healthspan products are effective, sponsors need to run complex, long, and expensive clinical trials. Few companies invest in this risky regulatory pathway, hindering healthspan innovation.

To address these difficulties, The Kitalys Institute, in partnership with The Healthspan Action Coalition, created the THRIVE Act, which proposes a new, optional approval pathway for healthspan products without modifying or replacing existing regulations around non-healthspan products.

To coordinate the review of healthspan products, the THRIVE Act proposes the FDA Center for Healthspan Products.

A NEW REGULATORY PATHWAY

The THRIVE Act regulatory pathway consists of three tiers of approval:

TIER 1

For products reasonably likely to increase healthspan

Requires a variety of clinical and preclinical evidence

Five years of market exclusivity

TIER 2

For products likely to increase healthspan

Requires at least one clinical trial, with other data as needed

Five additional years of market exclusivity

TIER 3

For products with substantial evidence of effectiveness

Requires well-controlled clinical trials with diverse, representative populations

Five additional years of market exclusivity

Sponsors are encouraged to ultimately obtain Tier 3 approval for all products, according to the process below:

Tier 1 approval

within one year of Tier 1 approval

Sponsor must begin clinical trial for Tier 2 application

Marketing

within ten years of marketing

within five years of marketing

Tier 3 approval

Tier 2 approval

within two years of Tier 2 approval

Tier 3 approval

Sponsor must begin clinical trial for Tier 3 application

If a product is unable to reach the next tier, it may be withdrawn or, provided it continues to be safe, accompanied by a disclosure of the limited evidence supporting it.

PRIORITY REVIEW VOUCHERS

The THRIVE Act proposes transferable priority review vouchers in the following cases:

EMERGING COMPANIES

a Breakthrough Healthspan Drug Designation, OR

first Tier 2 or 3 approval of a drug or supplement targeting two or more major chronic, age-related diseases

LARGE COMPANIES

a Breakthrough Healthspan Drug Designation, OR

first Tier 3 approval of a drug or supplement targeting two or more major chronic, age-related diseases

REPURPOSED GENERICS

Tier 2 or 3 approval for a repurposed generic drug (a drug originally approved for a non-healthspan indication, which the sponsor has repurposed for a healthspan indication)

ADDITIONAL INCENTIVES

In addition to the tiered regulatory pathway and priority vouchers, the THRIVE Act introduces the incentives below:

BREAKTHROUGH HEALTHSPAN PRODUCT DESIGNATION

for high-impact products that prevent or reverse two or more major chronic, age-related diseases

HEALTHSPAN INNOVATION PRIZES

up to five prizes of $100,000,000 each

for high-impact products that address two or more major chronic, age-related diseases at lower costs than standard interventions

THE THRIVE ACT

BACKGROUND

A NEW REGULATORY PATHWAY

TIER 1

For products reasonably likely to increase healthspan Requires a variety of clinical and preclinical evidence Five years of market exclusivity

TIER 2

For products likely to increase healthspan Requires at least one clinical trial, with other data as needed Five additional years of market exclusivity

TIER 3

For products with substantial evidence of effectiveness Requires well-controlled clinical trials with diverse, representative populations ​ Five additional years of market exclusivity

Tier 1 approval

Tier 1 approval

within one year of Tier 1 approval

Sponsor must begin clinical trial for Tier 2 application

Marketing

within ten years of marketing

within five years of marketing

Tier 3 approval

Tier 2 approval

within two years of Tier 2 approval

Tier 3 approval

Sponsor must begin clinical trial for Tier 3 application

PRIORITY REVIEW VOUCHERS

EMERGING COMPANIES

a Breakthrough Healthspan Drug Designation, OR first Tier 2 or 3 approval of a drug or supplement targeting two or more major chronic, age-related diseases

LARGE COMPANIES

a Breakthrough Healthspan Drug Designation, OR first Tier 3 approval of a drug or supplement targeting two or more major chronic, age-related diseases

REPURPOSED GENERICS

Tier 2 or 3 approval for a repurposed generic drug (a drug originally approved for a non-healthspan indication, which the sponsor has repurposed for a healthspan indication)

ADDITIONAL INCENTIVES

BREAKTHROUGH HEALTHSPAN PRODUCT DESIGNATION

for high-impact products that prevent or reverse two or more major chronic, age-related diseases

HEALTHSPAN INNOVATION PRIZES

up to five prizes of $100,000,000 each for high-impact products that address two or more major chronic, age-related diseases at lower costs than standard interventions

For products reasonably likely to increase healthspan

Requires a variety of clinical and preclinical evidence

Five years of market exclusivity

For products likely to increase healthspan

Requires at least one clinical trial, with other data as needed

Five additional years of market exclusivity

For products with substantial evidence of effectiveness

Requires well-controlled clinical trials with diverse, representative populations

Five additional years of market exclusivity

a Breakthrough Healthspan Drug Designation, OR

first Tier 2 or 3 approval of a drug or supplement targeting two or more major chronic, age-related diseases

a Breakthrough Healthspan Drug Designation, OR

first Tier 3 approval of a drug or supplement targeting two or more major chronic, age-related diseases

up to five prizes of $100,000,000 each

for high-impact products that address two or more major chronic, age-related diseases at lower costs than standard interventions